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Study Coordinator Ii Jobs
Company | DLH Corporation |
Address | Durham, NC, United States |
Employment type | FULL_TIME |
Salary | |
Category | Government Administration |
Expires | 2023-07-25 |
Posted at | 11 months ago |
About Us
- Assist with data collection, electronic data entry and audit checks.
- Provide other support to cover various study needs as directed.
- Support the development of procedures by facilitating discussions and tracking progress between investigator(s), and study team.
- Plan and coordinate the initiation of new protocols, including assisting with the development of protocol and consents, training materials, study specific SOPs and kick-off meetings.
- Work with a multidisciplinary team to develop SOPs and work processes to ensure the provision of the highest quality services.
- Coordinate the day-to-day study activities including recruitment, eligibility screening, scheduling, consenting, data collection, sample collection, lab processing/transfer or shipment, and problem resolution.
- Collaborate with multidisciplinary teams to support clinical research protocol implementation, data collection and human subject protection.
- Track study milestones, enrollment progress and ensure completion occurs on target.
- Follow local laws and regulations, NIH guidelines, SOPs and specific protocol procedures. Ensure study protocols and regulatory requirement for assigned studies are being followed.
- Serve as a primary study team contact and facilitate regular study communications and meetings with the team.
- Prepare and submit regulatory packages to the Institutional Review Board (IRB); maintain regulatory documents and compliance with regulation and protocols.
- Contribute to the development of new study procedures, including data collection forms, electronic databases, and checklists.
- Prepare ad hoc, progress and technical reports.
- Passion and dedication to research
- Ability to write clearly and concisely for regulatory reporting and submissions
- Strong attention to details and documentation practices
- Ability to effectively communicate verbally and in writing
- Ability to multi-task and manage time effectively
- Proactive and self-directed, with an ability to take direction as needed
- Ability to plan, prioritize and organize workflow and procedures
- Ability to pivot to meet changing requirements as needed
- Experience with protocol development and consent writing
- Experience drafting regulatory submissions for IRB
- Experience working at a clinical research site and/or conducting federal clinical research
- Strong proficiency with MS Word, Outlook, and Excel; full MS Office experience preferred
- Familiarity with investigator-initiated IND trials and FDA regulations
- Four or more years supporting clinical trials or clinical research in an applied setting that fosters development of the skills described above.
- Minimum of 2 years of experience as a study coordinator in a clinical research facility or comparable organization.
- Bachelor’s degree or equivalent combination of training and experience in public health, clinical research or related field. Master’s degree preferred.
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